BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30G X 8MM BD PEN NEEDLE

    MDR report key: 6315970 · Received February 9, 2017

    Report

    Report Number
    9616656-2017-00012
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    January 25, 2017
    Report Date
    March 30, 2017
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SAMPLES WERE NOT RETURNED, HOWEVER THE CUSTOMER PROVIDED SEVEN PHOTOS OF THE AFFECTED DEVICE FOR EVALUATION. A PHOTO INSPECTION REVEALED A NEEDLE PENETRATING ITS SHIELD. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6202786. CONCLUSION: BASED ON THE RETURNED PHOTOS, THE POTENTIAL ROOT CAUSE FOR THIS INCIDENT LIES AT THE SHIELDING STATION IN THE ASSEMBLY PROCESS. THE MOST PROBABLE REASON IS RELATED TO THE SET-UP ALIGNMENT OF THE SHIELD LOADER STATION. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO EMPLOYEES OBTAINED NEEDLE STICK INJURIES AFTER GIVING A PATIENT AN INSULIN INJECTION WITH A 30G X 8MM BD PEN NEEDLE. THIS OCCURRED WHILE THEY WERE RECAPPING THE NEEDLE. THE INITIAL REPORTER DECLINED TO PROVIDE ANY ADDITIONAL INFORMATION FOR THESE INCIDENTS, THEREFORE, IT IS UNKNOWN IF ANY MEDICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103595 30G X 8MM BD PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6202786

    Patients

    Seq Age Sex Outcome Treatment
    1 Other